Article Text
Abstract
Objective To evaluate long-term clinical, functional and radiographic outcomes in an open-label extension (OLE) study in patients with rheumatoid arthritis (RA) receiving adalimumab monotherapy or adalimumab+methotrexate following attainment of low disease activity (LDA) with adalimumab+methotrexate.
Methods Methotrexate-naive patients with early RA were randomised to adalimumab, methotrexate or adalimumab +methotrexate in a double-blind, 2-year study. Patients who completed the study and achieved LDA (28-joint Disease Activity Score using C reactive protein (DAS28(CRP)<3.2) could receive adalimumab monotherapy for up to 8 additional years in the OLE; open-label methotrexate could be added per investigator’s discretion. This post hoc analysis included data up to OLE year 3 (study year 5) from patients receiving adalimumab+methotrexate who achieved LDA at year 2 followed by adalimumab monotherapy or methotrexate reinitiation. Normal physical function was defined as Disability Index of the Health Assessment Questionnaire <0.5 and radiographic non-progression as change in modified total Sharp score ≤0.5.
Results Of 140 patients initiating adalimumab monotherapy, 84 (60%) received adalimumab only (methotrexate non-use) and 56 (40%) reinitiated methotrexate (methotrexate use) during OLE treatment. Median (IQR) time to first methotrexate use was 5.1 (0.1–31.4) weeks. Among methotrexate users, 61% retained LDA, 48% achieved DAS28(CRP) <2.6, 45% had normal physical function and 46% had no radiographic progression at year 5; for non-users, 63%, 50%, 58% and 50%, respectively, achieved these milestones. Adverse event rates were similar between methotrexate non-use and use patients.
Conclusions Adalimumab monotherapy effectively maintained good clinical, functional and radiographic outcomes for up to 3 additional years in ≥50% of patients who attained LDA after 2 years of adalimumab+methotrexate therapy.
Trial registration number NCT00195663; Post-results.
- anti-tnf
- methotrexate
- rheumatoid arthritis
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Footnotes
Contributors All authors participated in the interpretation of data, the preparation, review and approval of the manuscript and the decision to submit for publication.
Funding AbbVie funded the study (NCT00195663); contributed to the design; was involved in the collection, analysis and interpretation of the data and in the writing, review and approval of the publication.
Competing interests ECK has received consulting fees or other remuneration from, and served on advisory boards on behalf of, Abbott Laboratories, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Crescendo Bioscience, F. Hoffmann-La Roche Inc., Genentech Inc., Janssen Inc., Lilly Pharmaceuticals, Merck and Pfizer Pharmaceuticals; has received research grants from Abbott Laboratories, Amgen Inc., AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc., Janssen Inc., Lilly Pharmaceuticals, Novartis Pharmaceuticals, Pfizer Pharmaceuticals and Sanofi-Aventis and has speaker honoraria agreements with Abbott Laboratories, Amgen, AstraZeneca LP, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Pfizer Pharmaceuticals and Sanofi Genzyme. FCB has received consulting fees or other remuneration from Centocor, Schering-Plough, Amgen/Wyeth and Abbott. HK, YL, IS and SF are employees of AbbVie and may own AbbVie stock and/or stock options.
Patient consent Not required.
Ethics approval A central institutional review board or independent ethics committee approved the study at each participating site.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.